FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Amendia
DI: 08718375865293
·
Model: 4014-00
·
Technomed Engineering B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Amendia
- Primary DI
- 08718375865293
- Version / Model
- 4014-00
- Company Name
- Technomed Engineering B.V.
- Labeler DUNS
- 418415568
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-27
- Public Version
- 5
- Public Version Date
- 2025-02-17
- Public Version Status
- Update
- Public Device Record Key
- 8b84495e-34b6-4d73-82e3-537ae5717ef4
- Distribution End Date
- 2021-12-14
Device Description
Docent Disposable Neuro Monitoring Probe 3mm x 214mm electrode; 50mm wire with DIN42802 connector; OD 3.8mm x ID 3mm x 190mm sheath; 2m extension cable with DIN42802 connector
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXZ | Electrode, Needle | Neurology | 882.1350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61089 | Nerve-locating system probe, single-use | A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08718375865347 | GS1 | Pouch | 1 | Not in Commercial Distribution | 2021-12-14 |
| Primary | 08718375865293 | GS1 |
Customer Contacts
- Phone
- +31434086868
- [email protected]